3D Breast Ultrasound Elastography in Patients Under Neoadjuvant Chemotherapy

NCT ID: NCT01531036

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-11-30

Brief Summary

Breast Ultrasound Elastography is a complementary technique permitting a better characterization of breast lesions. 3D breast ultrasound elastography is a novel technique permitting a volumetric calculation of lesion stiffness. This could be particularly useful in patients with large breast tumors under pre-operative chemotherapy

Detailed Description

3D breast ultrasound elastography provides volumetric lesion stiffness details in real time. 3D acquisition is compared to breast MRI in order to evaluate volume measurements calculated in ultrasound. Lesion elasticity is calculated in 3 planes with immediate reconstruction. The purpose of this prospective study is to evaluate the feasibility of this technique and compare the results to those of Breast MRI. For women receiving preoperative chemotherapy, this technique will be evaluated with regard to tumour shrinkage and lesion elasticity modifications under treatment.

Conditions

Malignant Breast Tumours

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

shear wave imaging

Single arm study evaluating breast 3D elastography by means of shear wave propagation into breast tissue.

Group Type: EXPERIMENTAL

3D Ultrasound elastography by means of shear wave propagation into breast tissue

Intervention Type: DEVICE

Aixplorer Supersonic Imagine Ultrasound System with 3D probe for real-time elastography

Interventions

3D Ultrasound elastography by means of shear wave propagation into breast tissue

Aixplorer Supersonic Imagine Ultrasound System with 3D probe for real-time elastography

Intervention Type: DEVICE

Other Intervention Names

Aixplorer Supersonic Imagine

Eligibility Criteria

Inclusion Criteria

• Patients having already undergone a breast MRI
• Patients presenting with breast lesions measuring between20-50mm in ultrasound

Exclusion Criteria

• Multifocal lesions
• History of breast cancer
• Breast implants
• Inflammatory breast disease
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandra Athanasiou, MD

Role: PRINCIPAL_INVESTIGATOR

Curie Cancer Institute

Locations

Curie Cancer Institute

Paris, , France

Countries

France

References

Athanasiou A, Latorre-Ossa H, Criton A, Tardivon A, Gennisson JL, Tanter M. Feasibility of Imaging and Treatment Monitoring of Breast Lesions with Three-Dimensional Shear Wave Elastography. Ultraschall Med. 2017 Jan;38(1):51-59. doi: 10.1055/s-0034-1398980. Epub 2015 Mar 5.

Reference Type: BACKGROUND

PMID: 25741668 (View on PubMed)

Athanasiou A, Tardivon A, Tanter M, Sigal-Zafrani B, Bercoff J, Deffieux T, Gennisson JL, Fink M, Neuenschwander S. Breast lesions: quantitative elastography with supersonic shear imaging--preliminary results. Radiology. 2010 Jul;256(1):297-303. doi: 10.1148/radiol.10090385. Epub 2010 May 26.

Reference Type: BACKGROUND

PMID: 20505064 (View on PubMed)

Other Identifiers

2010-A00663-36

Identifier Type: REGISTRY

Identifier Source: secondary_id

C10-02

Identifier Type: -

Identifier Source: org_study_id